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510(k) K192989

Device
Libertas E-XLPE Modular Liner
Applicant
Maxx Orthopedics, Inc.
510(k) number
K192989
Product code
OQI  
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-29
Date received
2019-10-25
Regulation
888.3353
Classification name
Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Priscilla Herpai
Address
2460 General Armistead Ave. Suite 100 Norristown PA US 19403 19403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OQI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252451EPORE® XO cup systemImplantcast GmbH2026-04-24
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018-06-12
K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.2018-03-12
K111481CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USA2012-02-06

Legacy Summary#

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FDA Review#

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